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Glubrava (pioglitazone;metformin)

Region

🇪🇺 EU

Active substance

pioglitazone;metformin

Company

Takeda Pharma A/S

Status

Withdrawn

Therapeutic area

Diabetes Mellitus, Type 2

EU approval

Tue 11 Dec 2007

Application

EMEA/H/C/000893

ATC

A10BD05

Official record

www.ema.europa.eu

Indication

Glubrava is indicated as second line treatment of type-2-diabetes-mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone. After initiation of therapy with pioglitazone, patients should be reviewed after three to six months to assess adequacy of response to treatment (e.g. reduction in HbA1c). In patients who fail to show an adequate response, pioglitazone should be discontinued. In light of potential risks with prolonged therapy, prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained.

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Competact Authorised · CHEPLAPHARM Arzneimittel GmbH

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.